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COMPLETED NA

Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers

NCT00711100 · View on ClinicalTrials.gov ↗

Study Summary

Recently, tobacco companies have developed new oral tobacco products that are purportedly less harmful than conventional tobacco products. These products have not been tested by independent research for their health effects or consumer palatability. In addition, it is not known if these products will be used in addition to cigarette smoking or as a substitute to cigarettes. These two studies will examine four oral tobacco products to answer some of these questions. The goals of this first study will be to examine: 1) the brand of oral tobacco products which is preferred by cigarette smokers and the pattern and amount of product use when used as a switching tool; 2) the characteristics that are associated with product choice; 3) nicotine exposure from these products; and 4) the withdrawal symptoms from the tobacco products and potential for continued use. Specifically, our primary aims hypotheses were: 1) the product that will be chosen by most smokers will be based on taste and sensory aspects of the product with products higher in nicotine content more likely to be chosen as the preferred product; and 2) subjects will experience no difficulty using the product for complete cigarette substitution, but a small minority will engage in dual product use. For the secondary aims, we hypothesized: 1) that compared to the subjects' own brand of cigarettes, the biomarkers for exposure for the oral tobacco products will be significantly lower; 2) withdrawal symptoms from the oral products are likely to occur, but are likely to be mild compared to cigarette withdrawal.

Conditions Studied

Interventions

  • OTHER Camel Snus
  • OTHER Marlboro Snus
  • OTHER Stonewall
  • OTHER Ariva
  • OTHER General Snus

Study Locations (2)

Minnesota

  • Univeristy of Minnesota — Minneapolis

Oregon

  • Oregon Research Institute — Eugene

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2008-08
Est. Completion 2010-12
Phase NA

Sponsor

University of Minnesota

919 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00711100

The ClinicalTrials.gov registry entry for NCT00711100 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 919 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Tobacco Use Disorder appearing as the primary indexed condition, and to 5 interventions — of which Camel Snus is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00711100 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Minnesota, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00711100 about?

NCT00711100 is a clinical study titled "Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers". Recently, tobacco companies have developed new oral tobacco products that are purportedly less harmful than conventional tobacco products. These products have not been tested by independent research for their health effects or consumer palatability. In addition, it is not known if these products wil...

What is the current status of trial NCT00711100?

This trial is currently completed. It is a NA study. The enrollment target is 104 participants. The study started on 2008-08. Estimated completion is 2010-12.

What conditions does trial NCT00711100 study?

This clinical trial studies the following conditions: Tobacco Use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00711100?

The interventions under investigation include: Camel Snus (OTHER), Marlboro Snus (OTHER), Stonewall (OTHER), Ariva (OTHER), General Snus (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00711100?

This trial is sponsored by University of Minnesota, which has 919 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00711100 being conducted?

This trial has 2 study locations across Minnesota, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial